The MR9620-CFR is the FDA 21 CFR Part 11-compliant security software for the Accuris MR9620 SmartReader Multimode Plate Reader — the regulated-workflow software variant of the SmartReader Multimode PC software family. Distinct from the standard MR9620-PC Research Version software by the addition of audit-trail, electronic-signature, user-authentication, and data-integrity features required for FDA 21 CFR Part 11 compliance in regulated workflows (clinical labs, pharma R&D, GMP-environment QC labs).
Key Specifications
| SKU | MR9620-CFR |
| Type | PC software — FDA 21 CFR Part 11 compliant security version |
| Function | Regulated-workflow SmartReader Multimode chassis control + audit trail + electronic signature + user authentication + data integrity |
| Compatible chassis | MR9620 SmartReader Multimode Plate Reader (115 V) |
| Sister software | MR9620-PC (Research Version — non-regulated workflows, lower price point) |
| Compliance framework | FDA 21 CFR Part 11 (electronic records and electronic signatures for regulated workflows) |
What This Software Does
FDA 21 CFR Part 11 compliance requires regulated-workflow software to provide:
- Audit trail — every data-record creation, modification, and deletion is logged with user ID, timestamp, and reason
- Electronic signature — sample-batch results require electronic signature from authorized users for regulatory record validity
- User authentication — role-based user accounts with password complexity, login lockout, and session timeout
- Data integrity & closed-system controls — hash-based / cryptographic verification preventing undetected modification after signature, with data access limited to authenticated users and export controls for data leaving the system
The MR9620-CFR adds these features to the MR9620 chassis's standard control software, enabling the chassis to serve regulated workflows where the Research Version (MR9620-PC) cannot be used for compliance reasons.
CFR vs PC — Software Variant Selection
The MR9620 chassis ships with two software variant options:
| Software SKU | Version | Use case |
| MR9620-PC | Research Version | Non-regulated workflows — academic research, R&D, exploratory work; lower price point |
| MR9620-CFR (this SKU) | FDA 21 CFR Part 11 Security Version | Regulated workflows — clinical labs, pharma GMP-environment QC, validated assays |
Pick MR9620-CFR when the lab's workflow falls under any FDA 21 CFR Part 11 regulated scope: clinical diagnostic workflows producing data used for patient diagnosis or treatment decisions; pharma R&D under FDA submission where the assay data are part of an IND, NDA, BLA, or similar submission; GMP-environment quality control for pharma manufacturing or biopharmaceutical bioprocess QC; clinical trial data collection subject to FDA submission requirements; and veterinary diagnostic workflows under FDA-regulated frameworks.
Pick MR9620-PC for academic research, industrial R&D not under FDA submission, exploratory drug-discovery, and other non-regulated workflows.
Compatibility & When to Order This SKU
Software pairing — MR9620 chassis only. Order this SKU when:
- Commissioning a new MR9620 for regulated workflow — pair the chassis purchase with the CFR software license at install time.
- Upgrading an existing MR9620-PC install for regulated-workflow expansion — when the lab's workflow scope expands to include regulated assays, swap the Research Version license for the CFR Security Version.
- Multi-instrument MR9620 fleet under regulated framework — institutional labs running multiple MR9620 chassis under FDA 21 CFR Part 11 require the CFR software on each chassis.
- Audit-readiness — labs preparing for FDA inspection, ISO 17025 audit, or similar regulatory audits where the SmartReader chassis is part of the audit scope.
Application Profile
Clinical diagnostic labs running microplate-reader assays — clinical chemistry, immunoassay, and molecular diagnostic workflows producing patient-result data.
Pharma GMP-environment QC labs — pharma manufacturing QC running release-test microplate-reader assays.
Validated bioassay workflows — biopharma bioassay development and release-test workflows requiring 21 CFR Part 11 software.
Clinical trial data-collection workflows — multi-site clinical trial workflows where MR9620 microplate-reader assays produce trial outcome data.
Multi-site regulated lab consistency — multi-site operations standardizing on MR9620-CFR for consistent regulated-workflow software across sites.
Ordering & Configuration
License model. Per Accuris standard software-license terms — confirm at quote whether the license is per-instrument, per-user, perpetual, or subscription-based.
Validation documentation. Regulated-workflow software requires validation documentation (IQ/OQ/PQ — installation qualification, operational qualification, performance qualification). Confirm at order whether the software ships with validation documentation or requires separate validation-services purchase.
Software updates and patches. 21 CFR Part 11 software requires controlled software-update workflow; confirm at order whether updates are included in the license or require separate maintenance / support contract.
Confirm at quote: chassis pairing (MR9620 in inventory), license model (per-instrument vs per-user), validation documentation (IQ/OQ/PQ availability), institutional QM framework requirements (FDA 21 CFR Part 11 specifically; ISO 17025 supplementary), training requirements, and lead time.
Warranty: Per Accuris software-license terms — confirm at quote.
MR9620 SmartReader Multimode software stack:
- MR9620-CFR (this product) — FDA 21 CFR Part 11 Security Software (regulated workflows)
- MR9620-PC — Research Version software (non-regulated workflows)
Pick the CFR variant when the workflow falls under FDA 21 CFR Part 11 regulated scope; pick PC for academic and exploratory R&D.
